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DermTech's Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years

NCT04563949 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 323

Last updated 2021-03-26

No results posted yet for this study

Summary

This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification. Subjects who had, or will have a DermTech Pigmented Lesion Assay completed on a lesion suspected of being melanoma are eligible for the study. Based on historical data, an expected melanoma rate of approximately 5% to 10% is anticipated.

Conditions

  • Melanoma Detection

Interventions

OTHER

Repeat Testing

Repeat Testing with the PLA will be conducted

Sponsors & Collaborators

  • DermTech

    lead OTHER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2020-11-12
Completion
2020-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04563949 on ClinicalTrials.gov